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Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 36 - 36
1 Oct 2018
Hamilton WG Brenkel I Barnett SL Allen PW Lesko J Dwyer K Kantor SR Clatworthy M
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Introduction

New implants for total knee arthroplasty (TKA) are frequently introduced with the promise of improved performance. Infrequently there is accompanying data to document relative performance. The goal of this study was to evaluate the outcomes of an implant widely used for decades (Existing TKA), compared to a new implant (New TKA) from the same manufacturer.

Methods

From October 2011-March 2015, 19 sites prospectively enrolled and implanted 752 Subjects with Existing TKA. Between November 2012 and May 2015, 23 sites (18 sites had enrolled Existing TKAs), implanted 1131 Subjects with the New TKA. Demographics were similar between groups. Subjects were seen preoperatively, <1-year, 1-year, and 2-years to collect patient reported outcome measures (PROMs), radiographs and any complications. PROMs consisted of Knee Injury and Osteoarthritis Outcome Score (KOOS) (permits WOMAC scoring), Oxford Knee Score (OKS), Patient's Knee Implant Performance (PKIP) and EQ5D-3L and a p-value of 0.01 was established for statistical significance for PROMs comparisons. Kaplan-Meier (KM) implant survivorship (revision of any component for any reason) estimates were calculated.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 49 - 49
1 Feb 2017
Huey V Brenkel I Chang C Clatworthy M Hamilton W Howard J Kantor S Lesko J Nunley R Whittaker J Verdonk P
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Introduction

With the introduction of new technology in orthopaedics, surgeons must balance anticipated benefits in patient outcomes with challenges or complications associated with surgical learning curve for the technology. The purpose of this study was to determine whether the surgeon learning curve with a new multi-radius primary TKA system (primary TKA implant and instruments) designed for surgical team ease would impact clinical outcomes, surgical time and complications.

Materials & Methods

From November 2012 to July 2015, 2369 primary TKAs were prospectively enrolled in two multicenter studies across 50 sites in 14 countries with a new knee system (ATTUNEĀ®) evenly balanced across four configurations: cruciate retaining or posterior stabilised with either fixed bearing or rotating platform (CRFB, CRRP, PSFB, PSRP). 2261 knees had a <1 year visit and 1628 had a greater than 1 year visit. These knees were compared to a reference dataset of 845 primary TKAs from three manufacturers in the same four configurations with currently available products (CURRENT-TKA). Demographics for ATTUNE and CURRENT-TKA were similar and typical for primary TKA. Operative times, clinical outcomes and a series of five patient reported outcomes were compared for ATTUNE vs. CURRENT-TKA. The first 10 ATTUNE subjects for each surgeon were defined as learning curve cases (N=520) and were compared to all later subjects (N=1849) and also with the CURRENT-TKA cases (N=845). Patient reported outcome measures and clinical outcome analyses were adjusted for covariates including patient demographics, pre-op assessment and days post-op.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 88 - 88
1 Nov 2016
Howard J Brenkel I Chang C Clatworthy M Hamilton W Howard J Huey V Kantor S Lesko J Nunley R Verdonk P
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With the introduction of new technology in orthopaedics, surgeons must balance anticipated benefits in patient outcomes with challenges or complications associated with surgical learning curve for the technology. The purpose of this study was to determine whether surgeon learning curve with a new multi-radius primary TKA system and instruments designed to improve surgical team ease would impact clinical outcomes, surgical time, and complications.

From November 2012 to July 2015, 2369 primary TKAs were prospectively enrolled in two multicentre studies across 50 sites in 14 countries with a new knee system (NEW-TKA) evenly balanced across four configurations: cruciate retaining or posterior stabilised with either fixed bearing or rotating platform (CRFB, CRRP, PSFB, PSRP). 2128 knees had a<1 year visit and 1189 had a minimum 1 year visit. These knees were compared to a reference dataset of 843 primary TKAs from three manufacturers in the same four configurations with currently available products (CA-TKA). Demographics for NEW-TKA and CA-TKA were similar and typical for primary TKA. Operative times, clinical outcomes and a series of five patient reported outcomes were compared for NEW-TKA vs. CA-TKA. The first 10 New-TKA subjects for each surgeon were defined as learning curve cases (N=520) and were compared to all later subjects (N=1849). Patient reported outcome measure and clinical outcome analyses were covariate adjusted for patient demographics, pre-op assessment and days post-op.

Mean (SD) surgical time for NEW-TKA learning curve cases was 79.1 (24.3) minutes, which reduced thereafter to 73.6 (24.3) (p=0.002). Beyond 10 cases, there was a continued reduction in NEW-TKA surgical time (R-Squared = 0.031). After 10 cases, surgical time was on par with the mean (SD) 71.9 (21.6) for CA-TKA (p=0.078). PROM outcomes of the first 10 learning curve cases for NEW-TKA were not statistically different from later cases at less than 1 year or later when adjusted for relevant covariates including configuration, patient demographics, pre-op functional status, and time post-op (p-values > 0.01). PROM outcomes for NEW-TKA vs. CA-TKA under the same covariate adjustments showed a trend favoring KOOS ADL, Symptoms, and Sport and Recreation subscores at minimum 1 year (p-values < 0.01). The incidence of intraoperative operative site complications was 1.3% for the NEW-TKA learning curve cases which was similar to the 0.6% rate for historical CA-TKA (p=0.231) and the intraoperative complication rate for the NEW-TKA later cases was consistent with learning curve cases (p=0.158).

The introduction of new implants into the market place needs to have adequate data to support that they are safe and effective. Except for a minor increase in surgical time during the first 10 patients, this study found that surgeon learning curve with this new primary TKA system does not adversely affect patient short term outcomes and complication rates.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 9 - 9
1 May 2016
Adravanti P Guggi T D'Anchise R Dwyer K Lesko J Kape J
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INTRODUCTION

There is ongoing debate about the possible advantages of unicompartmental (UNI) knee replacement versus total knee replacement (TKR), such as for young, active patients. The purpose of this study was to investigate functional, radiographic, and device survivorship outcomes of UNI knee replacement with a newer generation UNI through 2-years post-op.

METHODS

A retrospective review of 188 cemented, fixed bearing unicompartmental (UNI) knee replacements implanted between January 2009 and June 2012 at 3 centers. The purpose of this study was to evaluate the survivorship, reasons for revision, radiographic and clinical results. A chart review was performed to collect demographics, operative details, American Knee Society (AKS) scores and adverse events (AE) through 2-years post-op. Kaplan-Meier (KM) device survivorship rates for the partial knee construct were estimated for post-op years in which at least 40 subjects had later follow-up. The definition of revision was the removal of any component for any reason, and device survivorship was the lack of revision. The time variable was the time to revision if the knee had been revised, or the time to last clinical follow-up or death if the knee had not been revised.

The average follow-up was 2.03 years (SD=0.4). The mean age was 64 years (SD=10.5), 56% of the patients were 65 years or younger, mean BMI was 27.5 kg/m2 (SD=4.9), 60% of patients were women, and 89% had a diagnosis of OA (9.6% had AVN). Data were collected through April 2015.